Post-cardiac SurgeryNCT04081987
Evaluation and Calibration of a Novel Non-invasive Wearable Device for Monitoring Vital Signs
An observational study of Post-cardiac Surgery and Intensive Care Unit Patients, run by BiPS Medical at 2 sites in Israel.
Trial summary
The purpose of this clinical study is to compare the measurement of vital signs (blood pressure, heart rate, respiration rate, blood oxygen levels and body temperature) measured by the non-invasive, continuous and wireless BiPS monitoring device with vital signs measured by current standard of care hospital equipment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-cardiac Surgery, Intensive Care Unit Patients
- What is being tested?
- non-invasive monitoring
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 2 sitesIsrael
- Study dates
- 20 Nov 2019to Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include a total of 50 adult patients that are connected to an arterial line as part of their routine care (e.g., post operative cardiac patients, or intensive care unit patients), recruited in Sourasky Medical Center (Ichilov), Tel-Aviv and Carmel Medical Center, Haifa.
Who may be able to join
- Patients aged 18 years and older who agree to sign an informed consent.
- Patients connected to an arterial line as part of their routine care (e.g., patients recovering from cardiac or other major surgery)
Who cannot join
- Pregnant women.
- Patients under the age of 18.
- Patients who are not connected to an arterial line as part of their routine care.
- Unable to give informed consent.
- Patients with poor or no finger pulse.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Recruiting
Carmel Medical Center
Haifa, 3436212
Ariela Goldenberg, RN, +48250288, ArielaGo1@clalit.org.il
- Not yet recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906
Inbal Wolpin, CRA, inbalw@tlvmc.gov.il
About this study
Official title: A Multi-center, Prospective, Pilot Study Intended for Data Collection to Evaluate and Calibrate a Novel Non-invasive Wearable Device for Monitoring Vital Signs
The purpose of this clinical study is to compare the measurement of vital signs (blood pressure, heart rate, respiration rate, blood oxygen levels and body temperature) measured by the non-invasive, continuous and wireless BiPS monitoring device with vital signs measured by current standard of care hospital equipment (blood pressure measurements will be obtained from arterial line) an invasive arterial line. The study will be conducted in two medical centers in Israel and include 50 adult patients that are connected to an arterial line as part of their routine care.
Read the detailed description
BiPS Medical has developed a wearable, wireless device that conveniently monitors important vital sign trends over time - blood pressure (diastolic \& systolic), heart and respiration rates, blood oxygen level (SPO2) and body temperature - to aid in identifying clinical deterioration. The device is base on a combination of inflatable mini finger cuff and photoplethysmograph technology.
The aim of this study is to collect data for evaluating and calibrating of the BiPS monitor for monitoring patient vital signs and compare it to current standard of care hospital monitors. The study population includes a total of 50 adult patients that are connected to an arterial line as part of their routine care. The BiPS non-invasive monitor will be attached to participating patients during their stay in the ICU/ recovery in cardiac ICU/Post Anesthesia Care Unit /other hospital designated unit. The device will be placed on the patient for 60 minutes while in hospital bed, in which up to 20 blood pressure measurements are performed (each takes up to 60 seconds). Heart and respiration rates, body temperature and SPO2 will be measured continuously while the device is attached to the patient hand.
- Conditions
- Post-cardiac Surgery, Intensive Care Unit Patients
- Being tested
- non-invasive monitoring
- Keywords
- Arterial line, Non-invasive monitoring, Vital signs, Blood pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive monitoringDevice
Comparing blood pressure (diastolic \& systolic), heart and respiration rates, blood oxygen level and body temperature measurement using the BiPS non-invasive monitor to an arterial line.
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of accordance between the BiPS monitor and the arterial line
Correlation between the vital sgns measured on The BiPS non-invasive monitor and those measured through the arterial line
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start20 Nov 2019
- Primary completionJan 2020 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BiPS Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tel-Aviv Sourasky Medical Center, Carmel Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04081987
- Sponsor's protocol ID
- BiPS
- Status last verified
- Jan 2020
- First submitted
- 4 Sep 2019
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The researchers will probably share the experimental results showing the level of accordance between the two measurement methods, but not the information of each participant separately.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Prospective, Pilot Study Intended for Data Collection to Evaluate and Calibrate a Novel Non-invasive Wearable Device for Monitoring Vital Signs
- ClinicalTrials.gov ID
- NCT04081987
- Acronym / sponsor ID
- BiPS
- Conditions
- Post-cardiac Surgery, Intensive Care Unit Patients
- Keywords
- Arterial line, Non-invasive monitoring, Vital signs, Blood pressure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- BiPS MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Tel-Aviv Sourasky Medical Center, Carmel Medical Center
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 9 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical study is to compare the measurement of vital signs (blood pressure, heart rate, respiration rate, blood oxygen levels and body temperature) measured by the non-invasive, continuous and wireless BiPS monitoring device with vital signs measured by current standard of care hospital equipment (blood pressure measurements will be obtained from arterial line) an invasive arterial line. The study will be conducted in two medical centers in Israel and include 50 adult patients that are connected to an arterial line as part of their routine care.
Detailed description
BiPS Medical has developed a wearable, wireless device that conveniently monitors important vital sign trends over time - blood pressure (diastolic \& systolic), heart and respiration rates, blood oxygen level (SPO2) and body temperature - to aid in identifying clinical deterioration. The device is base on a combination of inflatable mini finger cuff and photoplethysmograph technology.
The aim of this study is to collect data for evaluating and calibrating of the BiPS monitor for monitoring patient vital signs and compare it to current standard of care hospital monitors. The study population includes a total of 50 adult patients that are connected to an arterial line as part of their routine care. The BiPS non-invasive monitor will be attached to participating patients during their stay in the ICU/ recovery in cardiac ICU/Post Anesthesia Care Unit /other hospital designated unit. The device will be placed on the patient for 60 minutes while in hospital bed, in which up to 20 blood pressure measurements are performed (each takes up to 60 seconds). Heart and respiration rates, body temperature and SPO2 will be measured continuously while the device is attached to the patient hand.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include a total of 50 adult patients that are connected to an arterial line as part of their routine care (e.g., post operative cardiac patients, or intensive care unit patients), recruited in Sourasky Medical Center (Ichilov), Tel-Aviv and Carmel Medical Center, Haifa.
Key inclusion criteria (2 listed)
- Patients aged 18 years and older who agree to sign an informed consent.
- Patients connected to an arterial line as part of their routine care (e.g., patients recovering from cardiac or other major surgery)
Key exclusion criteria (5 listed)
- Pregnant women.
- Patients under the age of 18.
- Patients who are not connected to an arterial line as part of their routine care.
- Unable to give informed consent.
- Patients with poor or no finger pulse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-invasive monitoringComparing blood pressure (diastolic \& systolic), heart and respiration rates, blood oxygen level and body temperature measurement using the BiPS non-invasive monitor to an arterial line. | Device | – |
Primary outcome
Level of accordance between the BiPS monitor and the arterial line
Time frame: 60 minutes
Correlation between the vital sgns measured on The BiPS non-invasive monitor and those measured through the arterial line
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Individual participant dataSharing planned: Undecided. The researchers will probably share the experimental results showing the level of accordance between the two measurement methods, but not the information of each participant separately.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-cardiac Surgery and Intensive Care Unit Patients, run by BiPS Medical at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tomer Zaidenberg (+972-52-2793242, tomer@bipsmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of accordance between the BiPS monitor and the arterial line (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2020.